Extended Criteria For Fetal Myelomeningocele Repair
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies, Diabetes |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 16 - 45 |
| Updated: | 10/31/2018 |
| Start Date: | December 2015 |
| End Date: | January 2025 |
| Contact: | Kuojen Tsao, MD |
| Email: | KuoJen.Tsao@uth.tmc.edu |
| Phone: | 713-500-7327 |
Extended Criteria For Fetal Myelomeningocele Repair: A Pilot Study
The purpose of this study is to offer pre-natal Myelomeningocele (MMC) repair surgery to
pregnant women with one of the former surgery exclusion factors
- A BMI of 35-40 kg/m2
- Diabetes; patients will require good glycemic control
- History a previous preterm birth, as long as it was followed by a full term birth
- Structural abnormality in the fetus; abnormality must be minor, not increasing the risk
of prematurity. For example cleft lip and palate, minor ventricular septal defect,
pyelectasis.
- Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody that
is not associated with fetal disease, specifically anti-E < 1:4 or anti-M. Or
alloimmunization with negative fetal red blood cell antigen status determined by
amniocentesis.
We will be extending the Management of Myelomeningocele Study (MOMs) criteria by including
these factors. Prenatal clinical and outcome information will be collected; safety and
efficacy will be evaluated
pregnant women with one of the former surgery exclusion factors
- A BMI of 35-40 kg/m2
- Diabetes; patients will require good glycemic control
- History a previous preterm birth, as long as it was followed by a full term birth
- Structural abnormality in the fetus; abnormality must be minor, not increasing the risk
of prematurity. For example cleft lip and palate, minor ventricular septal defect,
pyelectasis.
- Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody that
is not associated with fetal disease, specifically anti-E < 1:4 or anti-M. Or
alloimmunization with negative fetal red blood cell antigen status determined by
amniocentesis.
We will be extending the Management of Myelomeningocele Study (MOMs) criteria by including
these factors. Prenatal clinical and outcome information will be collected; safety and
efficacy will be evaluated
The purpose of this study is to extend the MOMs requirements for pre-natal MMC repair surgery
and evaluate safety and efficacy. This will be accomplished through prenatal and
post-operative observation and data collection.
The data collected will be documented and collected from prenatal ultrasounds, operative, and
delivery reports. We will share our preliminary data with NAFTNet in order to prompt a
multicenter trial; this collaboration will help propagate further research and answer
clinical questions regarding this extension in surgery criteria.
and evaluate safety and efficacy. This will be accomplished through prenatal and
post-operative observation and data collection.
The data collected will be documented and collected from prenatal ultrasounds, operative, and
delivery reports. We will share our preliminary data with NAFTNet in order to prompt a
multicenter trial; this collaboration will help propagate further research and answer
clinical questions regarding this extension in surgery criteria.
Inclusion Criteria:
- Any woman with a prenatal diagnoses of myelomeningocele.
- Pre-pregnancy BMI of 35-40 kg/m2.
- Diabetes; patients will require good glycemic control
- History a previous preterm birth, as long as it was followed by a full term birth
- Structural abnormality in the fetus; abnormality must be minor, not increasing the
risk of prematurity. For example cleft lip and palate, minor ventricular septal
defect, pyelectasis.
- Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody
that is not associated with fetal disease, specifically anti-E < 1:4 or anti-M. Or
alloimmunization with negative fetal red blood cell antigen status determined by
amniocentesis.
- same MOMs Trial inclusion criteria with the exception of the above.
Exclusion Criteria:
- poor glycemic control (i.e., HbA1c ≥ 8%) in spite a medical antidiabetic therapy in
accordance with good clinical practice (GCP)
- presence of significant co-morbidities or complications (such as dyslipidemia,
uncontrolled arterial hypertension, impaired renal function, neuropathy, retinopathy,
CVD)
- severe diabetes complications or associated medical conditions (such as blindness,
endstage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure)
- recent (within preceding 12 months) myocardial infarction, stroke or TIA
- unstable angina pectoris
- same MOMs Trial exclusion criteria (with the exception of extended inclusion criteria)
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